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Clinical Informatics Manager
Data Management
Project Management
Charlottesville, VA
Horsham, PA
Lenexa, KS
Raleigh, NC
Regional North America
San Diego, CA
Victoria, British Columbia
12201BR






The Clinical Informatics Manager (CIM) is responsible for achieving successful delivery of Clinical Informatics activities by meeting internal and external sponsor requirements according to time, quality, scope, and budget constraints. The CIM holds primary accountability for Clinical Informatics activities and serves as primary liaison for technical vendors of third-party clinical informatics providers. The CIM is responsible for managing the overall delivery of clinical data management systems, system/data integrations, data transfer deliverables, database creation, analysis programming, drug safety and risk management, statistical analysis, medical writing and regulatory publishing services.
1. Ensures successful delivery of Clinical Informatics deliverables meeting internal and external sponsor needs by:
· Serving as primary sponsor liaison for Clinical Informatics activities
· Providing trial specific training, including protocol training
· Attending sponsor meetings and presenting as required
· Liaises with Data Quality Manager(DQM) and/or Clinical Informatics Leads to provide data as required to create performance metrics and trial status metrics
· Helping to ensure clinical data quality by partnering with the DQM, Clinical Informatics Specialist (CIS), and Drug Safety Associate (DSA) to assist with issues
·Works with the DQM and/or Clinical Informatics Leads to identify data issues and risks related to Clinical Informatics activities; develops contingency and mitigation plans to minimize risks; communicates risks & mitigation strategies as required
· Ensure Clinical Informatics deliverables are achieved in terms of timelines, quality, and budget
· Participate in sponsor and/or third party audits as well as address and respond to audit findings
2. Clinical Informatics Project Management:
· Authoring documents, including (but not limited to): Clinical Informatics Plan, Clinical Data Transfer Plan and the Database Unlocking Plan
· Tracking Clinical Informatics budget for assigned trials, identifying out of scope activities and escalating as appropriate utilizing the proper PRA systems
· May forecast units, hours and resourcing for Clinical Informatics tasks, determine worked units and hours, and analyze forecasted and worked activities to ensure adherence to contract and budget
· Addresses out-of-scope tasks from the Clinical Informatics team and escalates as needed
3. Performing dual function as Project Manager for trials/programs where only Clinical Informatics services are contracted:
· Authoring documents, including: Project Plan, Project Timelines
· Responsible for owning and achieving interim and final contractual deliverables for assigned trials/programs, according to the time, quality/scope and budget constraints.
· Owns forecasts of units/hours (revenue and resources), actual units/hours efficiency analysis
· Proactively identifies, negotiates and executes contract modifications for assigned trials, ensuring out of scope activities are approved up front via a contract modification
· Identifies potential or actual unrecoverable hours and provides analysis and mitigation/resolution plan for Senior Management approval
· Leads presentation of project risk reviews and is accountable for action item follow up
4. Vendor Management
· Responsible for Vendor Management of third party vendors when required
·  Responsible for implementation of vendor system in the trial
· Provides input regarding vendor selection activities
· Reviews vendor contracts and reviews or creates vendor system specifications to ensure system and data sponsor requirements are met
· Proactively identifies possible vendor issues and negotiates issue resolution activities
· Ensures applicable out of scope vendor activities are approved up front by the sponsor/vendor 
5. Contributes to Business Development as required

PRA is an Equal Employment Opportunity / Affirmative Action Employer


 (Minimum)

·        
Undergraduate degree or equivalent experience required. Undergraduate degree in allied health, bio-medical, information systems related field preferred.
·         Minimum 5 years experience in clinical research.
·         Excellent written and oral communication skills.
·        Proficiency in and experience managing the implementation of at least one Clinical Informatics system required.
·         Minimum 2 years experience in a lead role.
·         Project financial management experience required.
·         Experience managing technical vendors for system/data integration.
·         Proficient at utilizing systems to provide study and/or data metrics.
·         Familiar with clinical development and product life cycle terminology.
·         Experience working with data review committees preferred.
·         Regulatory submission knowledge and/or experience preferred.
·         Managing data deliverables according to CDISC standards preferred.